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Trial record 1 of 1 for:    NCT01529346
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Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

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ClinicalTrials.gov Identifier: NCT01529346
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 13, 2011
First Posted Date  ICMJE February 8, 2012
Results First Submitted Date  ICMJE February 21, 2018
Results First Posted Date  ICMJE June 1, 2018
Last Update Posted Date June 1, 2018
Actual Study Start Date  ICMJE December 12, 2011
Actual Primary Completion Date June 25, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) [ Time Frame: 0 to 6 hours ]
TOTPAR(6) was defined as the total area under pain relief (PR) curve through first 6 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0(none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during study up to 6 hours. Total score range for TOTPAR(6): 0 (worst) to 24 (best), higher value indicated greater degree of PR. Posterior mean, standard deviation were estimated based on analysis of covariance (ANCOVA) model with non-informative priors within outlier robust Bayesian framework.
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Total Pain Relief over the period from 0- 6 hr post dose (TOTPAR 6). TOTPAR 6 is defined as the area under the PR curve through the first 6 hours post-dosing. [ Time Frame: 0-6 hr post dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Number of Participants With Peak Pain Relief (PPR) [ Time Frame: 0 to 24 hours ]
    PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).
  • Pain Relief (PR) Score [ Time Frame: 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours ]
    PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).
  • Pain Intensity Difference (PID) [ Time Frame: 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours ]
    PID was calculated as pain intensity at baseline (baseline pain severity score range 2 [moderate] to 3 [severe]) minus pain intensity at the respective post-baseline visit (pain severity score range 0 [none] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).
  • Summed Pain Intensity Difference (SPID) [ Time Frame: 0 to 6 hours; 0 to 24 hours ]
    SPID: area under the PID effect curve from 0 to 6 hours (SPID[6]) and 0 to 24 hours (SPID[24]). AUC was calculated using the trapezoidal rule. Total score range: -6 (worst) to 18 (best) for SPID(6), and -24 (worst) to 72 (best) for SPID(24). Higher value of SPID indicated greater degree of pain relief. PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe).
  • Total Pain Relief From 0 to 24 Hours (TOTPAR[24]) [ Time Frame: 0 to 24 hours ]
    TOTPAR(24) was defined as the total area under the PR curve through the first 24 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during the study up to 6 hours. Total score range for TOTPAR (24): 0 (worst) to 96 (best), higher value indicated greater degree of PR. The least square mean and standard error are based on ANCOVA model with treatment as a fixed effect and baseline pain intensity as a covariate
  • Time to Onset of First Perceptible Pain Relief [ Time Frame: 0 to 24 hours ]
    Participants evaluated the time to first perceptible pain relief by stopping a stopwatch labeled 'first perceptible pain relief' at the moment they first began to experience any relief.
  • Time to Onset of Meaningful Pain Relief [ Time Frame: 0 to 24 hours ]
    Participants evaluated the time to first meaningful relief by stopping a stopwatch labeled 'meaningful pain relief' at the moment they first began to experience meaningful relief.
  • Time to First Use of Rescue Medication [ Time Frame: 0 to 24 hours ]
    Time to first use of rescue medication (acetaminophen 500 mg or hydrocodone 5 mg) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.
  • Number of Participants With Global Evaluation of Study Medication [ Time Frame: 6, 24 hours, prior to rescue medication (assessed up to 24 hours) ]
    Participant rated the study medication at 6 hours, 24 hours and immediately prior to rescue medication intake (only for participants who took rescue medication[RM]), on 5-point categorical scale: 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent.
  • Number of Participants With Study Medication Satisfaction [ Time Frame: 6, 24 hours, prior to rescue medication (assessed up to 24 hours) ]
    Participants provided assessment regarding satisfaction with study medication (SM) for pain relief (PR) and overall performance (OP) on a 5-point categorical scale, 1=very dissatisfied (VD), 2=somewhat dissatisfied (SD), 3=neither satisfied nor dissatisfied (NSND), 4=somewhat satisfied (SS) and 5=very satisfied (VS).
  • Plasma PF-05089771 Concentration [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose ]
  • Plasma Ibuprofen Concentration [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose ]
    Ibuprofen concentration was reported separately for 2 isomers of ibuprofen: (S)-Ibuprofen, and (R)-Ibuprofen, where S implied sinister (clockwise configuration) and R implied rectus (anti-clockwise configuration).
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 28 (follow-up) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to 28 days that were absent before treatment or that worsened relative to pretreatment state.
  • Number of Participants With Clinically Significant Laboratory Findings [ Time Frame: Baseline up to Day 7 to 10 (follow-up) ]
    Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes), blood chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, creatinine, blood urea nitrogen, fasting glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase), and urinalysis (urine white blood cells, urine red blood cells) were performed.
  • Number of Participants With Clinically Significant Vital Signs [ Time Frame: Baseline up to Day 7 to 10 (follow-up) ]
    Clinically significant vital signs: supine/sitting pulse rate (PR) less than (<) 40 or more than (>) 120 beats per minute (bpm), standing PR <40 or >140 bpm; systolic blood pressure (BP) >=30 millimeters of mercury (mmHg) change from baseline; absolute systolic BP <90 mmHg; diastolic BP >=20 mmHg change from baseline; absolute systolic BP <50 mmHg.
  • Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities [ Time Frame: Baseline up to Day 7 to 10 (follow-up) ]
    Clinically significant ECG abnormalities: PR interval >=300 milliseconds (msec); 25% increase from baseline in PR interval when baseline PR was >200 msec; an increase from baseline of >=50% in PR interval when baseline PR was <=200 msec; QRS interval >=140 msec; an increase from baseline of >=50% in QRS interval; corrected QT interval (QTc) >=500 msec.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
  • Peak Pain relief (PPR) [ Time Frame: 0-24 hr post dose ]
  • Time specific pain relief (PR) [ Time Frame: 0-24 hr post dose ]
  • Time-specific Pain Intensity Difference (PID) [ Time Frame: 0-24 hr post dose ]
  • Summed Pain Intensity Difference (SPID) [ Time Frame: 6 hr and 24 hr post dose ]
  • Total Pain Relief TOTPAR[24] (area under the PR curve through the first 24 hr post dose). [ Time Frame: 0-24 hr post dose ]
  • Time to perceptible pain relief (PR). At the time of dosing with study medication, 2 stopwatches will be started. Subjects will be instructed to stop the first stopwatch at the time they feel any pain relieving effect. [ Time Frame: 0-6 hr post dose. ]
  • Time to meaningful pain relief (PR). At the time of dosing with study medication, 2 stopwatches will be started. Subjects will be instructed to stop the second stopwatch when they feel the pain relief is meaningful to them. [ Time Frame: 0-6 hr post dose ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: 6 hr and 24 hr post dose and immediately prior to rescue medication. ]
  • Patient Satisfaction Questionnaire [ Time Frame: 6 hr and 24 hr post dose and immediately prior to rescue medication. ]
  • PK profile of PF-05089771 and ibuprofen [ Time Frame: Day 0 (pre-dose), 30 min, 60 min, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr and 24 hr post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Of PF-05089771 In Treating Postoperative Dental Pain
Official Title  ICMJE A Randomized, Double-blind, Double-dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-05089771 For The Treatment Of Postoperative Dental Pain Using Ibuprofen 400 Mg As Positive Control
Brief Summary The objective of this study is to evaluate the overall pain relief of a single dose of PF-05089771 against placebo following third molar extraction.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Dental Pain
Intervention  ICMJE
  • Drug: PF-05089771
    A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively
  • Other: Placebo
    Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
  • Drug: PF-05089771
    A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively
  • Drug: PF-05089771
    A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively
  • Drug: Ibuprofen
    2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively
  • Other: Placebo
    Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
  • Other: Placebo
    Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
  • Other: Placebo
    Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Study Arms  ICMJE
  • Experimental: PF-05089771 1600 mg
    Interventions:
    • Drug: PF-05089771
    • Other: Placebo
  • Experimental: PF-05089771 450 mg
    Interventions:
    • Drug: PF-05089771
    • Other: Placebo
  • Experimental: PF-05089771 150 mg
    Interventions:
    • Drug: PF-05089771
    • Other: Placebo
  • Active Comparator: Ibuprofen 400 mg
    Interventions:
    • Drug: Ibuprofen
    • Other: Placebo
  • Placebo Comparator: Placebo
    Interventions:
    • Other: Placebo
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2012)
235
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2012)
234
Actual Study Completion Date  ICMJE June 25, 2012
Actual Primary Completion Date June 25, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Oral surgery having removed 2 unilateral third molar teeth.
  • Pre-dose pain intensity score (100 mm VAS [VAS]) of at least 50mm within 5 hours of oral surgery
  • Pre-dose pain intensity score of moderate or severe within 5 hours of oral surgery

Exclusion Criteria:

  • Presence or known history of any clinically significant hematological, hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, allergic (including known drug hypersensitivities or allergies, but excluding untreated asymptomatic seasonal allergy) or any metabolic disorder that may increase risk associated with study participation, investigational drug administration or may interfere with interpretation of study results.
  • Prior use of any type of analgesic or NSAID within 5-half lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
  • Active dental infection at the time of surgery.
  • Recent (within the previous 12 months) history of chronic analgesic or tranquiliser dependency.
  • Any significant oral surgery complication at the time of surgery or in the immediate postoperative period, or oral surgery that has lasted more than 30 minutes (time from first incision to last suture placement).

Subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or use smokeless tobacco on a daily basis are excluded from the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529346
Other Study ID Numbers  ICMJE B3291009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP